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Saliva Collection Kit
EUDAMEDClass A (EU MDR)
Ref PS02005F04T2020Ref PS01005F04C2010
Identity
- Device Name
- Saliva Collection Kit EUDAMED
- Model / Reference
- PS02005F04T2020 EUDAMEDPS01005F04C2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895471749 EUDAMED06970895471916 EUDAMED
- Basic UDI-DI
- 697089547SC01Q3 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva Collection Kit by Jiangsu Mole Bioscience Co., LTD. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697089547SC01Q3 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 56783044-d355-4313-b4d5-c0d9730d92fe 61 fields · synced Jul 31, 2026
- EUDAMED c550201b-b1b9-4303-9881-981ae84c20c2 61 fields · synced May 19, 2026